oral complaints oral side effect
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Patients diagnosed with a hematological malignancy, who will receive FIC or RIC, followed by autologous or allogeneic HSCT * Patients older than 18 years. * Able and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: * Patients unable to give written informed consent. * Patients younger than 18 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: * Conditioning regimen (full intensity versus reduced intensity regimens with or without total body irradiation) and characteristics of subjective oral complications (e.g., pain, xerostomia, dysgeusia, dysphagia measured by patient reported outcomes) and objective oral complications (e.g., mucositis, infections, hemorrhage, gingivitis, periodontitis, dental caries, osteonecrosis and GVHD measured by validated scales) * Oral complications predictive for decreased QoL and negative clinical and economic outcomes (e.g., infections, use of antibiotics and opioid analgesics, parenteral nutrition, additional hospital visits, prolonged hospital stay, death) * Genetic polymorphisms in candidate genes (microarray analysis of salivary DNA samples) predictive for severe OM and GVHD | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional study parameters/endpoints of the Dutch side study: * Alterations of the oral microbial community (identified by open-end next generation sequencing) and in the salivary flow and proteome (MALDI-TOF, 2D-SDS PAGE and Mass Spectometry) in HSCT recipients developing severe OM and oral GVHD compared with those who do not. * Periodontal disease (measured by Plaque Index, Gingival Index, and Periodontal Pocket depth) predictive for developing severe OM and GVHD * Chronic oral GVHD and incidence and activity of dental caries (DMF-T and ICDAS-II score) * Alterations of the GI microbial community in HSCT recipients developing severe GI mucositis (diarrhea and citrulline levels) compared with those who do not | — |
Countries
Netherlands
Outcome results
None listed